By InvitationNot Applicable

Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

China500 participantsStarted 2022-04-13

Plain-language summary

The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Who can participate

Age range14 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 14-60 years;
✓. In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
✓. Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
✓. right-handed；
✓. The patient's family members signed the informed consent form;

Exclusion criteria

✕. The history of mental illness and a history of hearing impairment;
✕. Intracranial arterial clamp, pacemaker and other metal implants;
✕. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
✕. The presence of uncontrolled seizures or involuntary movements;
✕. The history of mental illness and a history of hearing impairment;
✕. Intracranial arterial clamp, pacemaker and other metal implants;
✕. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
✕. The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;

What they're measuring

Change from Coma recovery scale-revised

Timeframe: Within 24 hours of enrollment

Change from the p300 in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from resting-state in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from TEP in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from PCI in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Trial details

NCT IDNCT06097013

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Disorder of Consciousness trials

Who can participate

Age range14 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 14-60 years;
✓. In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
✓. Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
✓. right-handed；
✓. The patient's family members signed the informed consent form;

Exclusion criteria

✕. The history of mental illness and a history of hearing impairment;
✕. Intracranial arterial clamp, pacemaker and other metal implants;
✕. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
✕. The presence of uncontrolled seizures or involuntary movements;
✕. The history of mental illness and a history of hearing impairment;
✕. Intracranial arterial clamp, pacemaker and other metal implants;
✕. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
✕. The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;

What they're measuring

Change from Coma recovery scale-revised

Timeframe: Within 24 hours of enrollment

Change from the p300 in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from resting-state in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from TEP in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment

Change from PCI in electroencephalogram

Timeframe: Assessment within 24 hours before, and 1 hour after TMS treatment